Expandable interbody implant and methods of use

ABSTRACT

An intervertebral implant is provided. The intervertebral implant comprises a first component comprising an outer tissue engaging surface and an inner surface. A second component is connected to the first component, and is relatively moveable therefrom. The second component comprises an outer tissue engaging surface and an inner surface. The second component includes an actuator. A third component is disposed for engagement and is movable relative to the first and second components. The third component comprises at least a first ramp and a second ramp axially spaced apart from the first ramp. The actuator is engageable with the third component to effect axial translation of the wedge such that the ramps engage the inner surface of at least one of the first component and the second component to move the components between a first, collapsed configuration and a second, expanded configuration. Methods of use are disclosed.

TECHNICAL FIELD

The present disclosure generally relates to medical devices, systems andmethods for the treatment of musculoskeletal disorders, and moreparticularly to an expandable interbody implant system and method fortreating a vertebral column.

BACKGROUND

Spinal disorders such as degenerative disc disease, disc herniation,osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvatureabnormalities, kyphosis, tumor, and fracture may result from factorsincluding trauma, disease and degenerative conditions caused by injuryand aging. Spinal disorders typically result in symptoms including pain,nerve damage, and partial or complete loss of mobility. For example,after a disc collapse, severe pain and discomfort can occur due to thepressure exerted on nerves and the spinal column.

Non-surgical treatments, such as medication, rehabilitation and exercisecan be effective, however, may fail to relieve the symptoms associatedwith these disorders. Surgical treatment of these spinal disordersincludes fusion, fixation, discectomy, laminectomy and implantableprosthetics. These treatments may employ interbody implants. Thisdisclosure describes an improvement over these prior art technologies.

SUMMARY

Accordingly, an expandable interbody implant system and method aredisclosed. In one embodiment, an intervertebral implant is provided. Theintervertebral implant comprises a first component comprising an outertissue engaging surface and an inner surface. A second component isconnected to the first component, and is relatively moveable therefrom.The second component comprises an outer tissue engaging surface and aninner surface. The second component includes an actuator. A thirdcomponent is disposed for engagement and is movable relative to thefirst and second components. The third component comprises at least afirst ramp and a second ramp axially spaced apart from the first ramp.The actuator is engageable with the third component to effect axialtranslation of the wedge such that the ramps engage the inner surface ofat least one of the first component and the second component to move thecomponents between a first, collapsed configuration and a second,expanded configuration.

In one embodiment, an intervertebral implant comprises a pistoncomponent comprising an endplate surface and an inner surface disposedin an opposing orientation relative to the endplate surface. The pistoncomponent extends between an anterior end and a posterior end. A basecomponent comprises an endplate surface and an inner surface disposed inan opposing orientation relative to the endplate surface of the basecomponent. The base component extends between an anterior end and aposterior end. The base component is pivotably connected to the pistoncomponent adjacent the respective posterior ends. The posterior end ofthe base component includes a threaded cavity. A threaded screw isconfigured for disposal within the threaded cavity. A wedge is disposedfor engagement and is movable relative to the piston and basecomponents. The wedge comprises a first ramp having a first height and afirst angle of inclination and a second ramp having a second height anda second angle of inclination. The first ramp is axially spaced apartfrom the second ramp. The threaded screw is engageable with the wedge toeffect axial translation of the wedge such that the ramps engage theinner surface of the first component to pivot the first componentrelative to the second component such that the components expand betweena first, collapsed configuration and a second, expanded configuration.

In one embodiment, a method for treating a spine is provided. The methodcomprises the steps of: providing an intervertebral implant comprising:a first component having an anterior end and a posterior end, the firstcomponent comprising an outer tissue engaging surface and an innersurface; a second component having an anterior end and a posterior end,the second component being pivotably connected to the first componentadjacent the respective posterior ends, the second component comprisingan outer tissue engaging surface and an inner surface, the secondcomponent including an actuator, and a third component disposed forengagement and being movable relative to the first and secondcomponents, the third component comprising at least a first ramp and asecond ramp axially spaced apart from the first ramp; introducing theintervertebral implant in a collapsed configuration along asubstantially posterior approach of a body within an intervertebralspace; and engaging the actuator with the third component to effectaxial translation of the third component relative to the first andsecond components such that the ramps engage the inner surface of atleast one of the first component and the second component to expand theintervertebral implant to a second, expanded configuration.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a perspective view of one particular embodiment of an implantof a system in accordance with the principles of the present disclosure;

FIG. 2 is a perspective view of the implant shown in FIG. 1;

FIG. 3 is a side view of the implant shown in FIG. 1;

FIG. 4 is a side view of the implant shown in FIG. 1;

FIG. 5 is a side cross section view of the implant shown in FIG. 1;

FIG. 6 is a side cross section view of the implant shown in FIG. 1;

FIG. 7 is a perspective view of one embodiment of the components of theimplant shown in FIG. 1;

FIG. 8 is a perspective cutaway view of the implant shown in FIG. 1;

FIG. 9 is a plan view of one embodiment of the implant shown in FIG. 1;

FIG. 10 is a plan view of the implant shown in FIG. 9;

FIG. 11 is a perspective cutaway view of one embodiment of the implantshown in FIG. 1;

FIG. 12 is a side view of one embodiment of the implant shown in FIG. 1;

FIG. 13 is a side view of the implant shown in FIG. 12;

FIG. 14 is a side view of components of a system in accordance with theprinciples of the present disclosure disposed with vertebrae;

FIG. 15 is a side view of components of the system and vertebrae shownin FIG. 14;

FIG. 16 is a side view of components of the system and vertebrae shownin FIG. 14;

FIG. 17 is a perspective view of one embodiment of the implant shown inFIG. 1:

FIG. 18 is a perspective cutaway view of the implant shown in FIG. 17;

FIG. 19 is a perspective view of components of the implant shown in FIG.17;

FIG. 20 is a perspective cutaway view of the implant shown in FIG. 17;

FIG. 21 is a perspective cutaway view of the implant shown in FIG. 17;

FIG. 22 is a perspective view of one embodiment of the implant shown inFIG. 1:

FIG. 23 is a plan view of the implant shown in FIG. 22;

FIG. 24 is a side cross section view of the implant shown in FIG. 22;

FIG. 25 is a side cross section view of the implant shown in FIG. 22;

FIG. 26 is a side cross section view of the implant shown in FIG. 22;

FIG. 27 is a perspective view of one embodiment of the components of theimplant shown in FIG. 22; and

FIG. 28 is a perspective view of a component of the implant shown inFIG. 22.

DETAILED DESCRIPTION

The exemplary embodiments of an expandable interbody implant system andrelated methods of use disclosed herein are discussed in terms ofmedical devices for the treatment of musculoskeletal disorders and moreparticularly, in terms of an expandable interbody implant system andrelated methods for treating a vertebral column. It is envisioned thatthe implant system may provide, for example, fusion, decompression,restoration of sagittal balance and resistance of subsidence intotissue, such as, for example, surfaces of vertebral endplates. It isfurther envisioned that the system includes an interbody implant thatexpands after insertion into an intervertebral disc space and hasseveral features, such as, for example, facile insertion into theintervertebral disc space such that less bone removal is necessaryduring a surgical procedure, decompression of nerve roots, expansion torestore sagittal balance such that more expansion is provided on ananterior side relative to a posterior side in for example a lumbarapplication.

In one embodiment, the expandable interbody implant system is employedwith a posterior approach to the intervertebral disc space such that adistal end of the interbody implant expands more than a proximal end ofthe interbody implant to restore lordosis. In one embodiment, theexpandable interbody implant includes a base component that engages afirst vertebral endplate, a piston component that engages a secondvertebral endplate disposed in an opposing orientation and a double rampcomponent that is driven between the base and piston components to drivethe base and piston components apart. It is contemplated that the doubleramp component is moved relative to the base component via a malethreaded component. It is further contemplated that the double rampincludes two wedges that drive apart the piston and base components atthe proximal and distal ends of the expandable interbody implant. It isenvisioned that the height and angle of each wedge selectively providesan amount and rate of expansion on each end of the expandable interbodyimplant. For example, a steeper and/or taller wedge on a distal and/oranterior portion of the expandable interbody implant drives lordosis asthe interbody implant is expanded.

It is envisioned that the expandable interbody implant and methods ofuse disclosed herein can be employed to obtain fusion of vertebraethrough a minimally invasive or percutaneous technique. In oneembodiment, the disclosed expandable interbody implant and methods ofuse can provide improved spinal treatment with a device that is made toexpand vertically to create lordosis in vertebrae. It is contemplatedthat the expandable interbody implant and methods of use disclosedherein provide a cavity of relatively large volume for post-packing ofat least one agent, for example, bone graft.

It is envisioned that the present disclosure may be employed to treatspinal disorders such as, for example, degenerative disc disease, discherniation, osteoporosis, spondylolisthesis, stenosis, scoliosis andother curvature abnormalities, kyphosis, tumor and fractures. It iscontemplated that the present disclosure may be employed with otherosteal and bone related applications, including those associated withdiagnostics and therapeutics. It is further contemplated that thedisclosed expandable interbody implant may be alternatively employed ina surgical treatment with a patient in a prone or supine position,and/or employ various surgical approaches to the spine, includinganterior, posterior, posterior mid-line, medial, lateral,postero-lateral, and/or antero-lateral approaches, and in other bodyregions. The expandable interbody implant of the present disclosure mayalso be alternatively employed with procedures for treating the lumbar,cervical, thoracic and pelvic regions of a spinal column. The expandableinterbody implant and methods of the present disclosure may also be usedon animals, bone models and other non-living substrates, such as, forexample, in training, testing and demonstration.

The present disclosure may be understood more readily by reference tothe following detailed description of the disclosure taken in connectionwith the accompanying drawing figures, which form a part of thisdisclosure. It is to be understood that this disclosure is not limitedto the specific devices, methods, conditions or parameters describedand/or shown herein, and that the terminology used herein is for thepurpose of describing particular embodiments by way of example only andis not intended to be limiting of the claimed disclosure. Also, as usedin the specification and including the appended claims, the singularforms “a,” “an,” and “the” include the plural, and reference to aparticular numerical value includes at least that particular value,unless the context clearly dictates otherwise. Ranges may be expressedherein as from “about” or “approximately” one particular value and/or to“about” or “approximately” another particular value. When such a rangeis expressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment. It isalso understood that all spatial references, such as, for example,horizontal, vertical, top, upper, lower, bottom, outer, inner, terminal(denoting position or location), left and right, posterior, anterior,and the like, are for illustrative purposes only and can be variedwithin the scope of the disclosure. For example, the references“superior” and “inferior” are relative and used only in the context tothe other, and are not necessarily “upper” and “lower”.

Further, as used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure that may include administering one or more drugs to apatient in an effort to alleviate signs or symptoms of the disease orcondition. Alleviation can occur prior to signs or symptoms of thedisease or condition appearing, as well as after their appearance. Thus,treating or treatment includes preventing or prevention of disease orundesirable condition (for example, preventing the disease fromoccurring in a patient, who may be predisposed to the disease but hasnot yet been diagnosed as having it). In addition, treating or treatmentdoes not require complete alleviation of signs or symptoms, does notrequire a cure, and specifically includes procedures that have only amarginal effect on the patient. Treatment can include inhibiting thedisease, for example, arresting its development, or relieving thedisease, for example, causing regression of the disease. For example,treatment can include reducing acute or chronic inflammation;alleviating pain and mitigating and inducing re-growth of new ligament,bone and other tissues; as an adjunct in surgery; and/or any repairprocedure. Also, as used in the specification and including the appendedclaims, the term “tissue” includes soft tissue, ligaments, tendons,cartilage and/or bone unless specifically referred to otherwise.

The following discussion includes a description of an expandableinterbody implant and related methods of employing the expandableinterbody implant in accordance with the principles of the presentdisclosure. Alternate embodiments are also disclosed. Reference will nowbe made in detail to the exemplary embodiments of the presentdisclosure, which are illustrated in the accompanying figures. Turningnow to FIGS. 1-4, there is illustrated components of an interbodyimplant system including an intervertebral implant 40 in accordance withthe principles of the present disclosure.

The components of the system can be fabricated from biologicallyacceptable materials suitable for medical applications, includingmetals, synthetic polymers, ceramics and bone material and/or theircomposites, depending on the particular application and/or preference ofa medical practitioner. For example, the components of the system,individually or collectively, can be fabricated from materials such asstainless steel alloys, commercially pure titanium, titanium alloys,Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys,stainless steel alloys, superelastic metallic alloys (for example,Nitinol, super elasto-plastic metals, such as GUM METAL® manufactured byToyota Material Incorporated of Japan), ceramics and composites thereofsuch as calcium phosphate (for example, SKELITE™ manufactured byBiologix Inc.), thermoplastics such as polyaryl ether ketone (PAEK)including polyether ether ketone (PEEK), polyether ketone ketone (PEKK)and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO₄ polymericrubbers, polyethylene terephthalate (PET), fabric, silicone,polyurethane, silicone-polyurethane copolymers, polymeric rubbers,polyolefin rubbers, hydrogels, semi-rigid and rigid materials,elastomers, rubbers, thermoplastic elastomers, thermoset elastomers,elastomeric composites, rigid polymers including polyphenylene,polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone materialincluding autograft, allograft, xenograft or transgenic cortical and/orcorticocancellous bone, and tissue growth or differentiation factors,partially resorbable materials, such as, for example, composites ofmetals and calcium-based ceramics, composites of PEEK and calcium basedceramics, composites of PEEK with resorbable polymers, totallyresorbable materials, such as, for example, calcium based ceramics suchas calcium phosphate, tri-calcium phosphate (TCP), hydroxyapatite(HA)-TCP, calcium sulfate, or other resorbable polymers such aspolylactide, polyglycolide, polytyrosine carbonate, polycaprolactone andtheir combinations. Various components of the system may be fabricatedfrom material composites, including the above materials, to achievevarious desired characteristics such as strength, rigidity, elasticity,flexibility, compliance, biomechanical performance, durability andradiolucency or imaging preference. The components of the system,individually or collectively, may also be fabricated from aheterogeneous material such as a combination of two or more of theabove-described materials.

The system including intervertebral implant 40 can be employed as astabilization device in fusion and fixation procedures, for example, forpatients suffering from a spinal disorder to provide height restorationbetween vertebral bodies, decompression, restoration of sagittal balanceand/or resistance of subsidence into vertebral endplates. The componentsof the interbody implant system may be monolithically formed, integrallyconnected or include fastening elements and/or instruments, for example,as described herein.

Intervertebral implant 40 defines a longitudinal axis a and extendsbetween a first end, such as, for example, an anterior end 42 and asecond end, such as, for example, a posterior end 44. Intervertebralimplant 40 includes a first component, such as, for example, a pistoncomponent 46 and a second component, such as, for example, a basecomponent 48 connected to piston component 46. Base component 48 ismovably mounted to piston component 46 with a hinge 50 to facilitate apivoting connection between components 46, 48. Components 46, 48 arerelatively movable to expand and collapse with intervertebral implant 40between a first configuration and a second configuration, as will bedescribed. It is contemplated that components 46, 48 may bemonolithically formed and/or be connected via a living hinge. It isfurther contemplated that base component 48 may be alternativelyconnected to piston component 42 by integral connection, press fit,threaded, adhesive and/or fastening elements such as clips and/orscrews. It is envisioned that intervertebral implant 40 may include oneor a plurality of components.

Piston component 46 includes an outer tissue engaging surface, such as,for example, an endplate surface 52. Endplate surface 52 defines asubstantially rectangular opening 53 extending therethrough. It isenvisioned that opening 53 may be configured for packing of at least oneagent, for example, bone graft. It is further envisioned that opening 53may have alternate configurations, such as, for example, oval, oblong,triangular, square, polygonal, irregular, uniform, non-uniform, offset,staggered, undulating, arcuate, variable and/or tapered. It iscontemplated that endplate surface 52 may include one or a plurality ofopenings.

Endplate surface 52 is configured to engage an endplate of a vertebraand includes a plurality of raised elements 54 configured to enhancefixation and/or gripping with vertebral tissue. Elements 54 are disposedtransverse to longitudinal axis a. It is envisioned that all or only aportion of endplate surface 52 may have alternate surface configurationsto enhance fixation with tissue such as, for example, rough, arcuate,undulating, mesh, porous, semi-porous, dimpled and/or textured accordingto the requirements of a particular application. It is furtherenvisioned that elements 54 may be disposed at alternate orientations,relative to axis a, such as, for example, perpendicular and/or otherangular orientations such as acute or obtuse, co-axial and/or may beoffset or staggered.

Piston component 46 includes an inner surface 56 disposed to face anopposing orientation and/or direction relative to the facing orientationand/or direction of endplate surface 52. Endplate surface 52 is orientedin a direction to face tissue of a vertebral endplate and inner surface56 is oriented to face an opposite direction. Inner surface 56 issubstantially smooth or even and configured to engage a surface of athird component, such as, for example, a wedge 58 such that wedge 58 ismovable relative to components 46, 48.

Piston component 46 includes a first extension 60 and a second extension62 extending in a substantially linear configuration along longitudinalaxis a between a first end, such as, for example, an anterior end 64 anda second end, such as, for example, a posterior end 66. Extensions 60,62 are monolithically formed with ends 64, 66. It is envisioned thatextensions 60, 62 may be alternatively connected to ends 64, 66 byintegral connection, press fit, threaded, adhesive and/or fasteningelements such as hinge, clip and/or screws. Extensions 60, 62 aredisposed in a substantially parallel orientation relative tolongitudinal axis a. It is contemplated that extensions 60 and/or 62 maybe disposed at alternate orientations, relative to longitudinal axis a,for example, perpendicular, converging, diverging and/or other angularorientations such as acute or obtuse, co-axial and/or may be offset orstaggered. It is envisioned that extensions 60, 62 may extend inalternate configurations such as, for example, radius of curvature,offset and/or staggered. It is further envisioned that extensions 60, 62may have various cross section configurations, such as, for example,oval, oblong, triangular, rectangular, square, polygonal, irregular,uniform, non-uniform, variable, hollow and/or tapered.

Each of extensions 60, 62 include at least a portion of inner surface 56that engages at least a portion of the surface of wedge 58 to expand andcollapse intervertebral implant 40 between a first configuration and asecond configuration, as will be described. For example, each ofextensions 60, 62 include a planar portion 68 that engages basecomponent 48, a first inclined portion 70, a recess portion 72, atransition 74 and a second inclined portion 76. Portions 68, 70, 72, 74,76 are disposed in series along each of extensions 60, 62. Inclinedportions 70, 76 are disposed at an angle from axis a.

Base component 48 includes an outer tissue engaging surface, such as,for example, an endplate surface 78. It is envisioned that endplatesurface 78 may include one or a plurality of openings configured forpacking of at least one agent, for example, bone graft. Endplate surface78 is configured to engage an endplate of a vertebra and includes aplurality of raised elements 80 configured to enhance fixation and/orgripping with vertebral tissue. Elements 80 are disposed transverse tolongitudinal axis a. It is envisioned that all or only a portion ofsurface 78 may have alternate surface configurations to enhance fixationwith tissue similar to those alternatives described herein. It isfurther envisioned that elements 80 may be disposed at alternateorientations, relative to longitudinal axis a, similar to thosealternatives described herein.

Base component 48 includes an inner surface 82 disposed to face anopposing orientation and/or direction relative to the facing orientationand/or direction of endplate surface 78. Endplate surface 78 is orientedin a direction to face tissue of a vertebral endplate and inner surface82 is oriented to face an opposite direction. Inner surface 82 is planarand substantially smooth or even and configured to engage a surface ofwedge 58. Inner surface 82 engages the surface of wedge 58 such thatwedge 58 is movable relative to components 46, 48.

Base component 48 extends in a substantially linear configuration alonglongitudinal axis a between a first end, such as, for example, ananterior end 84 and a second end, such as, for example, a posterior end86. Posterior end 86 includes a wall 88 that defines an elongatedcavity, such as, for example, threaded opening 90. An actuator, such as,for example, a threaded screw 92 is configured for disposal withinthreaded opening 90 and extends to a distal end 94 that is fixed withwedge 58.

Screw 92 is rotatable relative to wall 88 in a first direction, such asclockwise, and a second opposing direction, such as counter clockwise.Screw 92 is configured to mate with threaded opening 90 in a threadedengagement and distal end 94 is fixed with wall 98 and freely rotatabletherein. Screw 92 is caused to engage opening 90 and rotated in aselected direction such that screw 92 is threaded with opening 90. Screw92 is configured for translation relative to wall 88 in a first axialdirection and a second axial direction.

Distal end 94 includes a flange 96 that engages a wall 98 of wedge 58 toretain screw 92 with wedge 58, as shown in FIGS. 5 and 6. Distal end 94extends through wall 98 and includes a reduced diameter 100 such thatdistal end 94 rotates relative to wall 98 to facilitate axialtranslation of screw 92 and wedge 58. Reduced diameter 100 facilitatesengagement of an adjacent surface 102 of screw 92 with wall 98 to driveand axially translate wedge 58, in a first direction shown by arrow A.Flange 96 engages wall 98 to draw and axially translate wedge 58, in asecond opposing direction shown by arrow B.

Screw 92 is fixed with wedge 58 to effect axial translation of wedge 58such that wedge 58 is movable relative to components 46, 48 to expandand collapse intervertebral implant 40 between a first configuration anda second configuration, as will be described. Screw 92 is engaged withan instrument or tool (not shown), to facilitate actuation of thecomponent parts of intervertebral implant 40 and disposal thereof invarious configurations according to the requirements of a particularapplication.

Base component 48 is pivotably connected to piston component 46 adjacentposterior ends 66, 86 with hinge 50 to facilitate a pivoting connectionbetween components 46, 48. Posterior end 66 includes a pin 104configured for disposal within an elongated slot 106 of posterior end86. Pin 104 is movable along an axis transverse to longitudinal axis aalong slot 106 to facilitate expansion and collapse of intervertebralimplant 40 between a first configuration and a second configuration.

Wedge 58 is disposed in an intermediate orientation with components 46,48. Wedge 58 includes a first surface 107 that engages component 46 anda second surface 108 that engages component 48 such that wedge 58 ismovable for axial translation relative to components 46, 48. Wedge 58includes a first rail portion 110 and a second rail portion 112,disposed along longitudinal axis a, which movably engage components 46,48 to expand and collapse intervertebral implant 40 between a firstconfiguration and a second configuration.

Rail portion 110 includes a first ramp, such as, for example, ananterior wedge portion 114 and a second ramp, such as, for example, aposterior wedge portion 116. Anterior wedge portion 114 is axiallyspaced apart from posterior wedge portion 116 along rail portion 110.Anterior wedge portion 114 has a first height h1 and a first angle ofinclination α1 relative to longitudinal axis a. It is envisioned thatheight h1 may be in a range of 3-7 millimeters (mm). It is furtherenvisioned that angle α1 may be in a range of 30 to 60 degrees.

Posterior wedge portion 116 has a second height h2 and a second angle ofinclination α2 relative to axis a. It is envisioned that height h2 maybe in a range of 1 to 5 mm. It is envisioned that angle α2 may be in arange of 4 to 30 degrees. In one embodiment, height h1 is greater thanheight h2. In one embodiment, angle α1 is greater than angle α2.

Rail portion 110 includes a protrusion 118 disposed between wedgeportions 114, 116 such that wedge portions 114, 116 are axially spacedapart and also connecting wedge portion 114 with wedge portion 116.Wedge portions 114, 116 and protrusion 118 are disposed in series alongrail portion 110. It is contemplated that wedge portions 114, 116 driveapart components 46, 48 at anterior end 42 and posterior end 44 tofacilitate expansion and collapse of intervertebral implant 40 between afirst configuration and a second configuration. It is furthercontemplated that the height and/or angle of wedge portions 114, 116regulates the amount and rate of expansion of intervertebral implant 40at least adjacent rail portion 110. It is envisioned that wedge portions114, 116 are monolithically formed, connected by fastening elements orseparate and distinct structure.

Rail portion 112 includes a third ramp, such as, for example, ananterior wedge portion 120 and a fourth ramp, such as, for example, aposterior wedge portion 122. Anterior wedge portion 120 is axiallyspaced apart from posterior wedge portion 122 along rail portion 112.Anterior wedge portion 120 has height h1 and angle of inclination α1.Posterior wedge portion 122 has height h2 and angle of inclination α2.

Rail portion 112 includes a protrusion 124 disposed between wedgeportions 120, 122 such that wedge portions 120, 122 are axially spacedapart. Protrusion 124 connects wedge portion 120 with wedge portion 122.Wedge portions 120, 122 and protrusion 124 are disposed in series alongrail portion 112. It is contemplated that wedge portions 120, 122 driveapart components 46, 48 at anterior end 42 and posterior end 44 tofacilitate expansion and collapse of intervertebral implant 40 between afirst configuration and a second configuration. It is furthercontemplated that the height and/or angle of wedge portions 120, 122regulates the amount and rate of expansion of intervertebral implant 40at least adjacent rail portion 112. It is envisioned that wedge portions120, 122 are monolithically formed, connected by fastening elements orseparate and distinct structure.

Each of rail portions 110, 112 include at least a portion of firstsurface 107 that engages at least a portion of inner surface 56 ofcomponent 46 to expand and collapse intervertebral implant 40 between afirst configuration and a second configuration. For example, theportions of surface 107 including wedge portions 114, 116 and protrusion118 disposed along rail portion 110 slideably engage portions 68, 70,72, 74, 76 disposed along extension 60. The portions of surface 107including wedge portions 120, 122 and protrusion 124 disposed along railportion 112 slideably engage portions 68, 70, 72, 74, 76 disposed alongextension 62. Each of rail portions 110, 112 also include at least aportion of surface 108 that slidably engages at least a portion of innersurface 82 corresponding to extensions 60, 62.

Rail portions 110, 112 extend in a proximal and/or posterior directionfor disposal about wall 88 adjacent posterior end 44. Rail portions 110,112 move about wall 88 during axial translation of the component partsof intervertebral implant 40.

In one embodiment, as shown in FIGS. 7 and 8, piston component 48includes a receptacle, such as, for example, a basket 202 configured fordisposal of at least one agent, for example, bone graft. Wedge 58includes a receptacle, such as, for example, a basket 204 configured fordisposal of at least one agent, for example, bone graft. In the first,collapsed configuration, baskets 202, 204 are disposed in series in aside by side configuration. As intervertebral implant 40 is expanded tothe second, expanded configuration, baskets 202, 204 translate to avertical stacked configuration such that bone graft can grow through theconnected baskets 202, 204. Each of baskets 202, 204 include a pluralityof openings that allow bone to grow between baskets 202, 204. In oneembodiment, basket 202 is an upper basket having a constant volume andbasket 204 is a lower basket having a constant volume. Baskets 202, 204are packed with bone graft prior to delivery to a surgical site anddisposed in series in a side by side configuration. Baskets 202, 204have ramped interfaces that allows baskets 202, 204 to maintain contacttherebetween as intervertebral implant 40 expands from the first,collapsed configuration to the second, expanded configuration, andbaskets 202, 204 transition from a side by side configuration to astacked and/or top to bottom configuration. This interface betweenbaskets 202, 204 has openings so that bone graft in one of baskets 202,204 can interface with bone graft in the other of baskets 202, 204. Thisconfiguration allows bone graft to fuse from a first vertebral endplatethrough basket 202 and through basket 204, or vice versa, to a secondvertebral endplate.

In one embodiment, as shown in FIGS. 9 and 10, intervertebral implant 40includes a bone graft cavity configured to have a controlled volume ofbone graft disposed with intervertebral implant 40. Intervertebralimplant 40 includes an opening 206 extending through its body andcomponents 46, 48 and 58. Opening 206 is configured for disposal of atleast one agent, for example, bone graft. In the first, collapsedconfiguration, opening 206 defines a length L1 and cross sectional areasuch that a volume v of bone graft is disposed within opening 206. Wall98 of wedge 58 is disposed in a proximal or posterior position. Asintervertebral implant 40 is expanded to the second, expandedconfiguration, the overall height of implant 40 increases and wall 98 istranslated axially in the direction shown by arrow A in FIG. 6, asdescribed herein. As wall 98 axially translates, the cross-sectionalarea of opening 206 is decreased. Wall 98 is translated to a distal oranterior position such that opening 206 defines a length L2. Thecomponents of intervertebral implant 40 are dimensioned such that adecrease in length of opening 206 to length L2 and the increase inheight of intervertebral implant 40 are combined to maintain asubstantially constant volume V of bone graft throughout expansion ofintervertebral implant 40. This allows intervertebral implant 40 tomaintain a constant volume of bone graft at any height of expansion. Itis contemplated that this configuration for maintaining bone graftvolume avoids the bone graft becoming loose within opening 206 asintervertebral implant 40 increases in height. It is furthercontemplated that tightly packed bone graft can potentially increasefusion capability. In one embodiment, intervertebral implant 40 providesa controlled volume of bone graft such that the components ofintervertebral implant 40 are dimensioned such that a decrease in lengthof opening 206 to length L2 occurs at a faster rate than the increase inheight of intervertebral implant 40. As such, the volume of bone graftis decreased as intervertebral implant 40 expands. This configuration ofintervertebral implant 40 compresses the bone graft as intervertebralimplant 40 is expanded. It is contemplated that the compressed bonegraft within intervertebral implant 40 can increase the likelihood offusion to occur from a first vertebral body through the bone graft intoa second vertebral body.

In operation, as shown in FIGS. 3-6, intervertebral implant 40 isengaged for disposal between a first configuration and a secondconfiguration such that intervertebral implant 40 expands in anintervertebral disc space. Intervertebral implant 40 is engaged with aninstrument (not shown) to facilitate actuation of the component parts ofintervertebral implant 40 according to the requirements of a particularsurgical application.

In a first configuration, such as, for example, a collapsedconfiguration (FIG. 5), components 46, 48 are disposed in a low profileorientation with wedge 58 such that planar portions 68 of extensions 60,62 are disposed in flush engagement with inner surface 82. Wedgeportions 114, 120 are disposed in flush engagement with the respectiveinclined portions 70 of extensions 60, 62 and wedge portions 116, 122are disposed in engagement with the respective inclined portions 76 ofextensions 60, 62. Protrusions 118, 124 are disposed within therespective recess portions 72 of extensions 60, 62.

Upon desired positioning of intervertebral implant 40 according to therequirements of a particular surgical application, screw 92 ismanipulated to move wedge 58 axially. The instrument engages screw 92for rotation in a clockwise direction. Screw 92 translates axially in afirst axial direction shown by arrow A. As screw 92 translates axially,surface 102 engages wall 98 to drive wedge 58 axially in the directionshown by arrow A. Wedge portions 114, 120 slidably engage the respectiveinclined portions 70 of extensions 60, 62 and wedge portions 116, 122slidably engage the respective inclined portions 76 of extensions 60,62. Such slidable engagement of the surfaces of wedge 58 and components46, 48, due to the axial translation of wedge 58, pivots component 46relative to component 48 in rotation about hinge 50 such that components46, 48 expand between the first collapsed configuration and a second,expanded configuration (FIG. 6). This configuration facilitatesexpansion of intervertebral implant 40 such that anterior end 42 has agreater rate and amount of expansion relative to posterior end 44. It iscontemplated that a steeper and/or taller anterior wedge portionfacilitates lordosis as intervertebral implant 40 is expanded.

In one embodiment, intervertebral implant 40 can be collapsed from theexpanded configuration to an alternate configuration between theexpanded and collapsed configurations, via manipulation of wedge 58 in asecond axial direction, as shown by arrow B in FIG. 6, opposite to thefirst axial direction. It is envisioned that reciprocal axial movementof wedge 58 to collapse intervertebral implant 40 may be desired toreposition or remove intervertebral implant 40 from a body cavity. Upondisposal of intervertebral implant 40 in the expanded configuration, todispose intervertebral implant 40 in an alternate configuration, screw92 is rotated in a counterclockwise direction such that flange 96engages wall 98 to draw and axially translate wedge 58, in the secondopposing direction shown by arrow B.

As wedge 58 is translated axially in the second axial direction,component 46 pivots about hinge 50 to rotate toward the collapsedconfiguration such that wedge portions 114, 120 move toward engagementwith the respective inclined portions 70, wedge portions 116, 122 movetoward engagement with the respective inclined portions 76 andprotrusions 118, 124 move toward disposal within the respective recessportions 72. Depending on the application, components 46, 48 may bereturned to the fully collapsed configuration, as shown in FIG. 5.

In one embodiment, as shown in FIG. 11, an actuator, such as, forexample, a turnbuckle 292 including clockwise threads 294 disposed at aproximal end 296 and being configured for disposal within threadedopening 90. Turnbuckle 292 includes counterclockwise threads 298disposed at a distal end 300 and being configured for threadedengagement with wedge 58. Wall 98 defines a threaded opening 302configured for disposal of threads 298. From a first collapsedconfiguration of intervertebral implant 40 described above, turnbuckle292 is manipulated to move wedge 58 axially. The instrument engagesturnbuckle 292 for rotation of threads 294 within threaded opening 90and rotation of threads 298 within opening 302 to drive expansion ofintervertebral implant 40. As turnbuckle 292 rotates, the counterrotation of threads 294, 298 causes turnbuckle 292 to drive apart wedge58 and base component 48 such that wedge 58 translates axially, asdescribed herein. The surfaces of wedge 58 and components 46, 48slidably engage as described above such that components 46, 48 expandbetween the first collapsed configuration and a second, expandedconfiguration.

In one embodiment, as shown in FIGS. 12 and 13, intervertebral implant40 is configured for selective and/or variable expansion between thefirst, collapsed configuration and the second, expanded configuration.It is envisioned that the shape and size of rail portions 110, 112 ofwedge 58 can selectively regulate expansion of intervertebral implant40. Wedge portions 114, 120 each include a first surface 402 having anangle of inclination β1 and a second surface 404 having an angle ofinclination β2. Wedge portions 116, 122 have an angle of inclination β1.Angle β2 is greater than angle β1.

Expansion of intervertebral implant 40 between the first and secondconfigurations includes an initial expansion and a secondary expansion.Wedge portions 116, 122 and surfaces 402 of wedge portions 114, 120 havean angle of inclination β1 such that, during the initial expansion,expansion of intervertebral implant 40 adjacent anterior end 42 andposterior end 44 is substantially equivalent, as shown by arrows X. Itis contemplated that initial expansion provides decompression of anintervertebral disc space. After a selected amount of expansion,according to the length of surface 402, inclined portion 70 of component46 engages surfaces 404 of wedge portions 114, 120 to override theexpansion due to wedge portions 116, 120. Angle β2 is greater than angleβ1 such that anterior end 42, as shown by arrow Y, expands a greateramount relative to posterior end 44, as shown by arrow Z. It iscontemplated that the secondary expansion expands an anterior side of anintervertebral disc space a greater amount relative to a posterior sideto provide lordosis. It is envisioned that other ramp configurations canbe used to expand intervertebral implant 40 in a vertical orientationonly, and/or to drive kyphosis in applications such as the thoracicspine.

In assembly and use, the interbody implant system is employed with asurgical procedure, such as, a fusion treatment of a spine of a patientincluding vertebrae V, intervertebral disc space I and body areasadjacent thereto, as discussed herein. The interbody implant system mayalso be employed with other surgical procedures, such as, for example,discectomy, laminotomy, laminectomy, nerve root retraction,foramenotomy, facetectomy, decompression, and spinal, nucleus or discreplacement.

For example, as shown in FIGS. 14-16, the interbody implant system canbe employed with a surgical arthrodesis procedure, such as, for example,an interbody fusion for treatment of an applicable condition or injuryof an affected section of a spinal column and adjacent areas within abody, such as, for example, intervertebral disc space I between firstvertebrae V1 and second vertebrae V2 of vertebrae V. It is contemplatedthat intervertebral implant 40 of the interbody implant system,described above, can be inserted with intervertebral disc space I tospace apart articular joint surfaces, provide support and maximizestabilization of vertebrae V. It is further contemplated thatintervertebral implant 40 provides height restoration between vertebralbodies, decompression, restoration of sagittal balance and/or resistanceof subsidence into vertebral endplates.

In use, to treat the affected section of vertebrae V, a medicalpractitioner obtains access to a surgical site including vertebrae V inany appropriate manner, such as through incision and retraction oftissues. It is envisioned that the interbody implant system can be usedin any existing surgical method or technique including open surgery,mini-open surgery, minimally invasive surgery and percutaneous surgicalimplantation, whereby vertebrae V is accessed through a mini-incision,or sleeve that provides a protected passageway to the area. Once accessto the surgical site is obtained, the particular surgical procedure isperformed for treating the spine disorder. Intervertebral implant 40,described above with regard to FIGS. 1-13, is then employed to augmentthe surgical treatment. Intervertebral implant 40 can be delivered orimplanted as a pre-assembled device or can be assembled in situ.Intervertebral implant 40 can be completely or partially revised,removed or replaced in situ. It is contemplated that one or all of thecomponents of the interbody implant system can be delivered to thesurgical site via manual manipulation and/or a free hand technique. Itis further contemplated that intervertebral implant 40 may be insertedposteriorly, and then manipulated anteriorly and/or lateral and/ormedial.

An incision is made in the body of a patient and a cutting instrument(not shown) creates a surgical pathway P for implantation ofintervertebral implant 40 within the patient body. A guide instrument(not shown) is employed to initially distract vertebrae V1 fromvertebrae V2, as shown in FIG. 14. A sleeve or cannula S is used toaccess intervertebral disc space I and facilitate delivery and accessfor components of the interbody implant system. A preparation instrument(not shown) can be inserted within the sleeve or cannula and disposedwithin intervertebral disc space I. The preparation instrument(s) can beemployed to remove some or all of the disc tissue including the discnucleus and fluids, adjacent tissues and/or bone, corticate, scrapeand/or remove tissue from the surfaces of endplates of opposingvertebrae V1, V2, as well as for aspiration and irrigation of the regionaccording to the requirements of a particular surgical application.

As shown in FIG. 15, intervertebral implant 40 is disposed in the first,collapsed configuration, described above and delivered through surgicalpathway P along a substantially posterior approach, as shown by arrow C,into intervertebral disc space I with a delivery instrument (not shown)including a driver. The driver delivers intervertebral implant 40 intothe prepared intervertebral disc space I, between vertebrae V1 andvertebrae V2, according to the requirements of a particular surgicalapplication.

Upon desired positioning of intervertebral implant 40, the driver orother instrument engages intervertebral implant 40 to facilitateactuation of the component parts of intervertebral implant 40. Thedriver engages screw 92 for rotation in a clockwise direction such thatscrew 92 translates axially to drive wedge 58 axially in the directionshown by arrow D in FIGS. 15 and 16. Wedge portions 114, 120 slidablyengage the respective inclined portions 70 of extensions 60, 62 andwedge portions 116, 122 slidably engage the respective inclined portions76 of extensions 60, 62, as shown and described with regard to FIGS. 5and 6. Such slidable engagement of the surfaces of wedge 58 andcomponents 46, 48, due to the axial translation of wedge 58, pivotscomponent 46 relative to component 48 in rotation about hinge 50 suchthat components 46, 48 expand between the first collapsed configurationand a second, expanded configuration, as shown in FIG. 16. Thisconfiguration facilitates expansion of intervertebral implant 40 suchthat anterior end 42 has a greater rate and amount of expansion relativeto posterior end 44. It is contemplated that in the expandedconfiguration, intervertebral implant 40 provides height restorationbetween vertebrae V1 and vertebrae V2, decompression, restoration ofsagittal balance and resistance of subsidence into the endplates ofvertebrae V and vertebrae V2.

It is envisioned that the components of the interbody implant system,which may include one or a plurality of intervertebral implants 40, canbe delivered to the surgical site via alternate approaches. In oneembodiment, intervertebral implant 40 is delivered through the surgicalpathway along a transforaminal lumbar interbody fusion approach intointervertebral disc space I and disposed in the expanded configuration.In one embodiment, a plurality of intervertebral implants 40 aredelivered through the surgical pathway along a posterior lumbarinterbody fusion approach into intervertebral disc space I and disposedin the expanded configuration in a side by side orientation.

In one embodiment, intervertebral implant 40 can be collapsed from theexpanded configuration to an alternate configurations between theexpanded and collapsed configurations, as described above, to collapseintervertebral implant 40 as may be desired to reposition with or removeintervertebral implant 40 from intervertebral disc space I. In oneembodiment, the interbody implant system includes a plurality ofintervertebral implants 40, which can be variously sized and configured,and/or oriented in a side by side engagement, spaced apart and/orstaggered.

In one embodiment, the interbody implant system includes an agent, whichcan include a bone growth promoting material, which may be disposed,packed or layered within, on or about the components and/or surfaces ofthe interbody implant system. The bone growth promoting material, suchas, for example, bone graft can be a particulate material, which mayinclude an osteoconductive material such as HA and/or an osteoinductiveagent such as a bone morphogenic protein (BMP) to enhance bony fixationof intervertebral implant 40 with the adjacent vertebrae V.

It is contemplated that the agent and/or bone graft may includetherapeutic polynucleotides or polypeptides. It is further contemplatedthat the agent and/or bone graft may include biocompatible materials,such as, for example, biocompatible metals and/or rigid polymers, suchas, titanium elements, metal powders of titanium or titaniumcompositions, sterile bone materials, such as allograft or xenograftmaterials, synthetic bone materials such as coral and calciumcompositions, such as HA, calcium phosphate and calcium sulfite,biologically active agents, for example, gradual release compositionssuch as by blending in a bioresorbable polymer that releases thebiologically active agent or agents in an appropriate time dependentfashion as the polymer degrades within the patient. Suitablebiologically active agents include, for example, BMP, Growth andDifferentiation Factors proteins (GDF) and cytokines. Intervertebralimplant 40 can be made of radiolucent materials such as polymers.Radiomarkers may be included for identification under x-ray,fluoroscopy, CT or other imaging techniques. It is envisioned that theagent may include one or a plurality of therapeutic agents and/orpharmacological agents for release, including sustained release, totreat, for example, pain, inflammation and degeneration.

In one embodiment, as shown in FIGS. 17-21, the interbody implant systemincludes an intervertebral implant 540, similar to intervertebralimplant 40 and its components described above with regard to FIGS. 1-16.Intervertebral implant 540 defines a longitudinal axis aa and extendsbetween an anterior end 542 and a posterior end 544. Intervertebralimplant 540 includes a piston component 546 and a base component 548connected to piston component 546. Base component 548 is movably mountedto piston component 546 with a hinge 550 to facilitate a pivotingconnection between components 546, 548. Components 546, 548 arerelatively movable to expand and collapse with intervertebral implant540 between a first configuration and a second configuration, as will bedescribed.

Piston component 546 includes an endplate surface 552. Endplate surface552 defines a substantially rectangular opening 553. Endplate surface552 is configured to engage an endplate of a vertebra and includes aplurality of raised elements 554 configured to enhance fixation and/orgripping with vertebral tissue. Elements 554 are disposed transverse tolongitudinal axis aa.

Piston component 546 includes an inner surface 556 disposed to face anopposing orientation and/or direction relative to the facing orientationand/or direction of endplate surface 552. Endplate surface 552 isoriented in a direction to face tissue of a vertebral endplate and innersurface 556 is oriented to face an opposite direction. Inner surface 556is substantially smooth or even and configured to engage a surface of awedge 558 such that wedge 558 is movable relative to components 546,548.

Piston component 546 includes a first extension 560 and a secondextension 562 extending in a substantially linear configuration alonglongitudinal axis aa between an anterior end 564 and a posterior end566. Extensions 560, 562 are monolithically formed with ends 564, 566.Extensions 560, 562 are disposed in a substantially parallel orientationrelative to longitudinal axis aa.

Each of extensions 560, 562 include at least a portion of inner surface556 that engages at least a portion of the surface of wedge 558 toexpand and collapse intervertebral implant 540 between a firstconfiguration and a second configuration. Each of extensions 560, 562include a portion 568 that engages base component 548, an inclinedportion 570 and a linear portion 576. Portions 568, 570, 576 aredisposed in series along each of extensions 560, 562. Inclined portion570 is disposed at an angle from axis aa.

Base component 548 includes an endplate surface 578. Endplate surface578 is configured to engage an endplate of a vertebra and includes aplurality of raised elements 580 configured to enhance fixation and/orgripping with vertebral tissue. Elements 580 are disposed transverse tolongitudinal axis aa. Base component 548 includes a wall 582 defining aninner surface configured to support slidable movement of wedge 558. Wall582 is disposed on opposing lateral sides of intervertebral implant 540such that wedge 558 is movable within an inner surface boundary of basecomponent 548. Endplate surface 578 is oriented in a direction to facetissue of a vertebral endplate and wall 582 is oriented to face wedge558. Wedge 558 is movable relative to components 546, 548 within theinner surface boundary of base 548.

Base component 548 extends in a substantially linear configuration alonglongitudinal axis as between an anterior end 584 and a posterior end586. Posterior end 586 includes wall portions 588 that supports anactuator, such as, for example, a threaded screw 592. Wall portions 588fix the position of screw 592 with base component 548 and facilitatefree rotation of screw 592 between wall portions 588. Screw 592 isconfigured for disposal between wall portions 588 and a threaded cavity,such as, for example, threaded slot 590 defined by a wall 591 of wedge558.

Screw 592 is rotatable relative to wall portions 588 and wall 591 in afirst direction, such as clockwise, and a second opposing direction,such as counter clockwise. Screw 592 is configured to mate with threadedslot 590 in a threaded engagement and freely rotatable therein. Screw592 is rotated in a clockwise direction such that engagement with slot590 axially translates wedge 558, in a first direction shown by arrow AAin FIGS. 20 and 21. Screw 592 is rotated in a counter clockwisedirection such that engagement with slot 590 axially translates wedge558, in a second opposing direction shown by arrow BB.

Screw 592 is fixed with component 548 to effect axial translation ofwedge 558 such that wedge 558 is movable relative to components 546, 548to expand and collapse intervertebral implant 540 between a firstconfiguration and a second configuration. Screw 592 is engaged with aninstrument or tool (not shown), to facilitate actuation of the componentparts of intervertebral implant 540 and disposal thereof in variousconfigurations according to the requirements of a particularapplication.

Base component 548 is pivotably connected to piston component 546adjacent posterior ends 566, 586 with hinge 550 to facilitate a pivotingconnection between components 546, 548. Posterior end 566 includes a pin604 configured for disposal within an elongated slot 606 of posteriorend 586. Pin 604 is movable along an axis transverse to longitudinalaxis aa along slot 606 to facilitate expansion and collapse ofintervertebral implant 540 between a first configuration and a secondconfiguration.

Wedge 558 is disposed in an intermediate orientation with components546, 548. Wedge 558 includes a first surface 607 that engages component546 and a second surface 608 that engages component 548 such that wedge558 is movable for axial translation relative to components 546, 548.Wedge 558 includes a first rail portion 610 and a second rail portion612, disposed along longitudinal axis aa, which movably engagecomponents 546, 548 to expand and collapse intervertebral implant 540between a first configuration and a second configuration.

Rail portion 610 includes a first ramp, such as, for example, ananterior wedge portion 614 and a second ramp, such as, for example, aposterior wedge portion 616. Anterior wedge portion 614 is axiallyspaced apart from posterior wedge portion 616 along rail portion 610.Anterior wedge portion 614 has a height and an angle of inclinationrelative to longitudinal axis aa, similar to that described above.Posterior wedge portion 616 has a height and an angle of inclinationrelative to axis aa, similar to that described above.

Rail portion 610 includes a member 618 disposed between wedge portions614, 616 such that wedge portions 614, 616 are axially spaced apart.Member 618 connects wedge portion 614 with wedge portion 616. Wedgeportions 614, 616 and member 618 are disposed in series along railportion 610. It is contemplated that wedge portions 614, 616 drive apartcomponents 546, 548 at anterior end 542 and posterior end 544 tofacilitate expansion and collapse of intervertebral implant 540 betweena first configuration and a second configuration. It is furthercontemplated that the height and/or angle of wedge portions 614, 616regulates the amount and rate of expansion of intervertebral implant 540at least adjacent rail portion 610. It is envisioned that wedge portions614, 616 are monolithically formed, connected by fastening elements orseparate and distinct structure.

Rail portion 612 includes a third ramp, such as, for example, ananterior wedge portion 620 and a fourth ramp, such as, for example, aposterior wedge portion 622. Anterior wedge portion 620 is axiallyspaced apart from posterior wedge portion 622 along rail portion 612.Wedge portions 620, 622 each have a height and angle of inclination,similar to that described above.

Member 618 is disposed between wedge portions 620, 622 such that wedgeportions 620, 622 are axially spaced apart. Member 618 connects wedgeportion 620 with wedge portion 622. Wedge portions 620, 622 and member618 are disposed in series along rail portion 612. It is contemplatedthat wedge portions 620, 622 drive apart components 546, 548 at anteriorend 542 and posterior end 544 to facilitate expansion and collapse ofintervertebral implant 540 between a first configuration and a secondconfiguration. It is further contemplated that the height and/or angleof wedge portions 620, 622 regulates the amount and rate of expansion ofintervertebral implant 540 at least adjacent rail portion 612. It isenvisioned that wedge portions 620, 622 are monolithically formed,connected by fastening elements or separate and distinct structure.

Each of rail portions 610, 612 include at least a portion of firstsurface 607 that engages at least a portion of inner surface 556 ofcomponent 546 to expand and collapse intervertebral implant 540 betweena first configuration and a second configuration. The portions ofsurface 607 including wedge portions 614, 616 disposed along railportion 610 slideably engage portions 570, 576 disposed along extension560. The portions of surface 607 including wedge portions 620, 622disposed along rail portion 612 slideably engage portions 570, 576disposed along extension 562.

Rail portions 610, 612 extend in a proximal and/or posterior directionfor disposal within wall portions 582 adjacent posterior end 544. Railportions 610, 612 move within wall portions 582 during axial translationof the component parts of intervertebral implant 40.

Piston component 548 includes a receptacle, such as, for example, abasket 702 configured for disposal of at least one agent, for example,bone graft. Wedge 558 includes a receptacle, such as, for example, abasket 704 configured for disposal of at least one agent, for example,bone graft. In the first, collapsed configuration, baskets 702, 704 aredisposed in series in a side by side configuration. As intervertebralimplant 540 is expanded to the second, expanded configuration, baskets702, 704 translate to a vertical stacked configuration such that bonegraft can grow through the connected baskets 702, 704. Each of baskets702, 704 include a plurality of openings that allow bone to grow betweenbaskets 702, 704.

In operation, as shown in FIGS. 20 and 21, intervertebral implant 540 isengaged for disposal between a first configuration and a secondconfiguration such that intervertebral implant 540 expands in anintervertebral disc space. Intervertebral implant 540 is engaged with aninstrument (not shown) to facilitate actuation of the component parts ofintervertebral implant 540 according to the requirements of a particularsurgical application.

In a first configuration, such as, for example, a collapsedconfiguration (FIG. 20), components 546, 548 are disposed in a lowprofile orientation with wedge 558. Upon desired positioning ofintervertebral implant 540 according to the requirements of a particularsurgical application, screw 592 is manipulated to move wedge 558axially, as described above. As wedge 558 axially translates in thedirection shown by arrow AA, wedge portions 614, 620, 616, 622 slidablyengage extensions 560, 562. Such slidable engagement of the surfaces ofwedge 558 and components 546, 548, due to the axial translation of wedge558, pivots component 546 relative to component 548 in rotation abouthinge 550 such that components 546, 548 expand between the firstcollapsed configuration and a second, expanded configuration (FIG. 21).This configuration facilitates expansion of intervertebral implant 540such that anterior end 542 has a greater rate and amount of expansionrelative to posterior end 544.

In one embodiment, intervertebral implant 540 can be collapsed from theexpanded configuration to an alternate configuration between theexpanded and collapsed configurations, via manipulation of wedge 558 ina second axial direction, as shown by arrow BB in FIGS. 20 and 21,opposite to the first axial direction. It is envisioned that reciprocalaxial movement of wedge 558 to collapse intervertebral implant 540 maybe desired to reposition or remove intervertebral implant 540 from abody cavity. Upon disposal of intervertebral implant 540 in the expandedconfiguration, to dispose intervertebral implant 540 in an alternateconfiguration, screw 592 is rotated in a counterclockwise direction suchthat wedge 558 axially translates, in the second opposing directionshown by arrow B. As wedge 558 is translated axially in the second axialdirection, component 546 pivots about hinge 550 to rotate toward thecollapsed configuration.

In one embodiment, as shown in FIGS. 22-26, the interbody implant systemincludes an intervertebral implant 840, similar to intervertebralimplant 40 and intervertebral implant 540 and their components describedabove. Intervertebral implant 840 includes a base component 848 having aposterior end 886 configured to attach to an inserter or tool (notshown) that engages a screw 892 for axially translating a wedge 858.Base component 848 includes a wedge shaped anterior end 884. Basecomponent 848 protects wedge 858 and screw 892 as intervertebral implant840 is inserted into an intervertebral disc space. It is contemplatedthat forces employed to introduce or deliver intervertebral implant 840to the intervertebral disc space are transmitted through the inserter toan anterior end 842 of intervertebral implant 840. A piston component846 includes an opening 847 and base component 848 includes an opening849. Openings 847, 849 are configured to receive radio-opaque markers.

Intervertebral implant 840 includes a linkage component 902 thatconnects piston component 846 to wedge 858. Linkage component 902 has afirst end 904 including a slot 906 that supports a pin 908 of pistoncomponent 846. Pin 908 is slidably supported with slot 906 for movementtherein. Linkage component 902 has a second end 910 connected by a pin912 with wedge 858.

Linkage component 902 has a passive configuration as intervertebralimplant 840 is expanded to the second, expanded configuration (FIG. 24),as described above with regard to intervertebral implants 40, 540. Inapplications that require intervertebral implant 840 to be collapsed, asdescribed herein, the linkage draws piston component 846 into thecollapsed configuration (FIG. 26). Linkage component 902 facilitatesdisposal of intervertebral implant 840 from the expanded configurationfor removal or repositioning of intervertebral implant 840 in theintervertebral disc space. It is envisioned that linkage component 902prevents bone graft and/or agents from undesirably engaging and/orinterfering with wedge 858 during axial translation. Wedge 858 includesopenings 859 that reduce material to reduce medical imaging scatter.

In one embodiment, as shown in FIGS. 27 and 28, intervertebral implant840 can be actively collapsed employing a pin and channel configuration.Piston component 846 includes pins 948 extending inwardly fromextensions 860, 862. Pins 948 are disposed within channels 950 formed inopposing side walls 952 of wedge 858. Pins 948 are disposed for slidablemovement within the configuration of channels 950. As intervertebralimplant 840 is collapsed, as described herein, wedge 858 is retractedvia axial translation. Channels 950 selectively guide pins along wedge858 to draw piston component 846 into the collapsed configuration. It isenvisioned that wedge 858 may include pins and piston component 846includes channels for drawing piston component 846 into the collapsedconfiguration. It is further envisioned that wedge 858 may include adovetail member for slidable movement within channels 950.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

1. An intervertebral implant comprising: a first component extendingalong a longitudinal axis and comprising an outer tissue engagingsurface and an inner surface; a second component connected to the firstcomponent such that the first component is pivotable relative to thesecond component about a pin extending transverse to the longitudinalaxis through openings in the first and second components, the secondcomponent comprising an outer tissue engaging surface and an innersurface, the second component including an actuator; and a thirdcomponent disposed for engagement and being movable relative to thefirst and second components, the third component comprising at least afirst ramp and a second ramp axially spaced apart from the first ramp,wherein the actuator is engageable with the third component to effectaxial translation of the third component such that the ramps engage theinner surface of one of the first component and the second component tomove the components between a first, collapsed configuration and asecond, expanded configuration. 2-16. (canceled)
 17. An intervertebralimplant as recited in claim 1 wherein the third component comprises afirst rail including the first ramp and the second ramp, and a secondrail including a third ramp and a fourth ramp, the third ramp beingaxially spaced apart from the third ramp.
 18. An intervertebral implantas recited in claim 1 wherein the first ramp includes a first surfacehaving a first angle of inclination and a second surface having a secondangle of inclination.
 19. An intervertebral implant comprising: a pistoncomponent comprising an endplate surface and an inner surface disposedin an opposing orientation relative to the endplate surface, the pistoncomponent extending along a longitudinal axis between an anterior endand a posterior end; a base component comprising an endplate surface andan inner surface disposed in an opposing orientation relative to theendplate surface of the base component, the base component extendingbetween an anterior end and a posterior end, the base componentpivotably connected to the piston component adjacent the respectiveposterior ends by a hinge such that the piston component is rotatablerelative to the base component about an axis of rotation transverse tothe longitudinal axis through at least one plane, the posterior end ofthe base component including a threaded cavity; a threaded screwconfigured for disposal within the threaded cavity; a wedge disposed forengagement and being movable relative to the piston and base components,the wedge comprising a first ramp having a first height and a firstangle of inclination and a second ramp having a second height and asecond angle of inclination, the first ramp being axially spaced apartfrom the second ramp, wherein the threaded screw is engageable with thewedge to effect axial translation of the wedge such that the rampsengage the inner surface of the first component to pivot the pistoncomponent relative to the base component such that the components expandbetween a first, collapsed configuration and a second, expandedconfiguration.
 20. (canceled)
 21. An intervertebral implant as recitedin claim 1 wherein: the third component comprises a first surface thatincludes the ramps and an opposite planar second surface; and the innersurface of the second component is planar and engages the second surfaceas the components move between the first, collapsed configuration andthe second, expanded configuration.
 22. An intervertebral implant asrecited in claim 1, wherein the inner surface of the first componentcomprises first and second inclined portions that slide along the firstand second ramps as the components move between the first, collapsedconfiguration and the second, expanded configuration.
 23. Anintervertebral implant as recited in claim 22, wherein the inclinedportions extend at an acute angle relative to the longitudinal axis. 24.An intervertebral implant as recited in claim 22, wherein the firstinclined portion extends at a first angle relative to the longitudinalaxis and the second inclined portion extends at a second angle relativeto the longitudinal axis, the first angle being greater than the secondangle.
 25. An intervertebral implant as recited in claim 24, wherein thefirst angle is 30 to 60 degrees and the second angle is 4 to 30 degrees.26. An intervertebral implant as recited in claim 1, wherein theactuator comprises a distal end and an opposite proximal end thatincludes a tool socket.
 27. An intervertebral implant as recited inclaim 26, wherein the pin is spaced apart from the third component andthe distal end of the actuator comprises a flange that engages a wall ofthe third component to retain the actuator with the third component andeffect translation of the third component in opposite directions alongthe longitudinal axis.
 28. An intervertebral implant as recited in claim1, wherein the first component comprises a first rail, a second rail andspaced apart first and second transverse walls that connect the firstrail with the second rail, a wall of the second component beingpositioned between the rails, the pin extending through the wall and therails to connect the first component with the second component.
 29. Anintervertebral implant as recited in claim 1, wherein the actuator isthreaded screw that is positioned within a threaded opening in thesecond component.
 30. An intervertebral implant as recited in claim 1,wherein the pin is disposed within an elongated slot of the secondcomponent such that the pin translates within the elongated slot as thecomponents move between the first, collapsed configuration and thesecond, expanded configuration.
 31. An intervertebral implant as recitedin claim 30, wherein the pin moves from a first end of the elongatedslot to an opposite second end of the elongated slot as the componentsmove between the first, collapsed configuration and the second, expandedconfiguration.
 32. An intervertebral implant as recited in claim 1,wherein the actuator is fixed with the third component.
 33. Anintervertebral implant as recited in claim 1, wherein the second andthird components each comprise a basket configured for disposal of bonegraft, the basked being disposed in series in a side by sideconfiguration when the components are in the first, collapsedconfiguration and in a vertical stacked configuration when thecomponents are in the second, expanded configuration.
 34. Anintervertebral implant as recited in claim 1, wherein the implantcomprises a cavity that extends through the first, second and thirdcomponents, the cavity having a constant volume as the components movebetween the first, collapsed configuration and the second, expandedconfiguration.
 35. An intervertebral implant as recited in claim 1,wherein the inner surface of the first component engages the innersurface of the second component when the components are in the first,collapsed configuration and the inner surface of the first component isspaced apart from the inner surface of the second component when thecomponents are in the second, expanded configuration.
 36. Anintervertebral implant comprising: a first component comprising an innersurface having spaced apart first and second inclined portions; a secondcomponent pivotably connected to the first component about a pinextending through openings in the first and second components; a thirdcomponent positioned between the first and second components, the thirdcomponent comprising at least a first ramp and a second ramp axiallyspaced apart from the first ramp; and an actuator that extends throughthe second component and into the third component to fix the actuatorwith the third component, the actuator being rotatable relative to thesecond component and comprising a threaded outer surface that engages athreaded inner surface of the second component, wherein rotation of theactuator relative to the second member causes the third member totranslate axially relative to the first and second members such that theramps slide along the inclined portions to move the components from afirst, collapsed configuration to a second, expanded configuration.